Using the Skindex-16 and Common Terminology Criteria for Adverse Events to assess rash symptoms: results of a pooled-analysis (N0993)

Support Care Cancer. 2012 Aug;20(8):1729-35. doi: 10.1007/s00520-011-1266-x. Epub 2011 Sep 16.


Background: Historically, skin toxicity has been assessed in prospective clinical trials using the clinician-reported National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). The patient-reported Skindex-16 measures symptoms and perceptions of toxicity. This study was designed to compare information provided by these two measures.

Methods: Data were compiled from three placebo-controlled North Central Cancer Treatment Group studies (N06C4, N03CB, N05C4) having rash prevention as the primary objective. All used the Skindex-16 and CTCAE at baseline, weekly during treatment and during a minimum 2-week follow-up period. Statistical procedures, including Pearson correlations, were utilized to determine relationships between adverse event (AE) grades and Skindex-16 scores.

Results: Four hundred and twelve individual patients provided data (median age, 61; 134 male). Patients' Skindex-16 score results show a 0.9 overall mean (range 0-6 with 6 being worse symptoms), a 0.4 baseline mean (range, 0-4.3) and a 1.3 end-of-treatment mean (range, 0-5.9). Ninety-three, 142 and 177 patients experienced a grade 0, 1 and 2+ CTCAE skin toxicity, respectively. Baseline Skindex-16 scores had relatively low correlation with CTCAE grades. The correlation of rash grade with Skindex-16 scores ranged from r = 0.49 with the function subscale to r = 0.62 with the symptom subscale. The highest correlations of the maximum grade of any dermatological AE with the Skindex-16 were r = 0.48 for the total score and r = 0.55 for the symptom subscale.

Conclusions: The data reported support the decision to include both measures in a clinical trial to assess the patient experience, as each measure may specifically target varying symptoms and intensities.

MeSH terms

  • Algorithms
  • Anti-Inflammatory Agents / therapeutic use
  • Antibodies, Monoclonal / adverse effects
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents / adverse effects*
  • Breast Neoplasms / radiotherapy
  • Cetuximab
  • Erlotinib Hydrochloride
  • Exanthema / chemically induced*
  • Exanthema / classification*
  • Female
  • Gefitinib
  • Humans
  • Male
  • Middle Aged
  • Mometasone Furoate
  • Neoplasms / complications*
  • Neoplasms / therapy*
  • Pregnadienediols / therapeutic use
  • Protein Kinase Inhibitors / adverse effects
  • Protein Synthesis Inhibitors / therapeutic use
  • Quinazolines / adverse effects
  • Radiodermatitis / classification*
  • Radiodermatitis / prevention & control
  • Randomized Controlled Trials as Topic
  • Severity of Illness Index*
  • Sunscreening Agents / therapeutic use
  • Surveys and Questionnaires
  • Terminology as Topic*
  • Tetracycline / therapeutic use


  • Anti-Inflammatory Agents
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antineoplastic Agents
  • Pregnadienediols
  • Protein Kinase Inhibitors
  • Protein Synthesis Inhibitors
  • Quinazolines
  • Sunscreening Agents
  • Mometasone Furoate
  • Erlotinib Hydrochloride
  • Tetracycline
  • Cetuximab
  • Gefitinib